A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer

Conditions

• Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fosbretabulin — DRUG
  Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
• Carboplatin — DRUG
  Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
• Paclitaxel — DRUG
  Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
• Bevacizumab — DRUG
  Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Study Details

The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus CA4P. The rationale for this study is the potential additive or synergistic actions of vascular disrupting agents like CA4P with anti-angiogenic agents like bevacizumab.

Key Dates

First listed

Apr 7, 2008

Start date

Mar 31, 2008

Status verified

Jan 2015

Primary completion

Jul 31, 2011

Completion

Oct 31, 2011

Study Design

Enrollment

63 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1: Chemotherapy+Bevacizumab
  Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.
• Experimental: Arm 2: Active Comparator+Fosbretabulin
  Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.

Primary Outcome Measure

Progression Free Survival (PFS) in the Intent-to-Treat Population [ Time Frame: Six 21-day cycles ]

Locations (15)

Find similar trials in Campbell, CA

Related Studies

• XACT ACE Observational Registry
  Recruiting · Xact Robotics Ltd. · Burlington, Massachusetts
• HP Pyruvate MRI in Cancers
  PHASE1/PHASE2 · Recruiting · University of Maryland, Baltimore · Baltimore, Maryland
• Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas